Randomized Sham-Controlled Trial Evaluating Efficacy and Safety of Endoscopic Gastric Plication for Primary Obesity: The ESSENTIAL Trial
Shelby Sullivan, James M. Swain, George E. Woodman, Michael Antonetti, Nestor de la Cruz-Muñoz, Sreenivasa S. Jonnalagadda, Michael Ujiki, Sayeed Ikramuddin, Jaime Ponce, Marvin Ryou, John Reynoso, Rishi Chhabra, Gregory B. Sorenson, W. Kyle Clarkston, Steven A. Edmundowicz, J. Christopher Eagon, Daniel K. Mullady, Danielle Leslie, Tammy Lavin, Christopher Thompson
- The ESSENTIAL trial tested a non-surgical weight loss procedure performed through the mouth using an endoscope, with no incisions or permanent digestive changes.
- This rigorous trial randomly assigned patients to real or sham procedures with blinding, ensuring results reflect true effect rather than placebo.
- Endoscopic weight loss procedures may suit patients with moderate obesity who haven't lost enough weight through diet and medications but aren't ready for surgery.
- Dr. de la Cruz-Muñoz served as a site principal investigator alongside leading researchers from Harvard and other top institutions.
- This is one of at least eight clinical trials for endoscopic and device-based weight loss therapies Dr. de la Cruz-Muñoz has participated in.
- This demonstrates offering the full range of treatment approaches from lifestyle counseling to endoscopic procedures to surgery.
This landmark multicenter, randomized, sham-controlled clinical trial (the ESSENTIAL trial) was published in Obesity and evaluated the efficacy and safety of endoscopic gastric plication using the Incisionless Operating Platform for primary weight loss in patients with obesity. The trial enrolled patients with Class I and II obesity across multiple US centers, randomizing them to the active endoscopic procedure or a sham procedure, with both groups receiving standardized lifestyle modification therapy. Dr. de la Cruz-Muñoz served as a site investigator.
Sullivan S, Swain JM, Woodman GE, Antonetti M, De La Cruz-Muñoz N, Jonnalagadda SS, Ujiki M, Ikramuddin S, Ponce J, Ryou M, Reynoso J, Chhabra R, Sorenson GB, Clarkston WK, Edmundowicz SA, Eagon JC, Mullady DK, Leslie D, Lavin T, Thompson C. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. Obesity (Silver Spring). 2017;25(2):294-301. doi:10.1002/oby.21702.
